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MaSTherCell – News – Servier appoints MaSTherCell for the development of its CAR-T cell therapy manufacturing platform
MaSTherCell
01.08.2017
Related Pages
Have an insight of the industry with Denis Beboret, Managing Director at MaSTherCell.
Detect how MaSTherCell is enabling cell therapy development, Interview with Denis Bedoret
25.07.2017
Outer Links
Related Pages
In this interview, Denis Bedoret, Managing Director at MaSTherCell, shares how the cell therapy industry has evolved in latest years and explains how MaSTherCell can help cell therapy companies.
- What are the challenges encountered in the industry?
- What is the MaSTherCell’s advantage?
- How can MaSTherCell help?
- The insight of the future of the cell therapy industry
CRISPR selected MaSTherCell for the development and cGMP manufacturing of CTX101
06.06.2017
Downloads
- Download the press release
Outer Links
Related Pages
BASEL, Switzerland, CAMBRIDGE, Mass. & Gosselies, Belgium. Jun 6, 2017 – CRISPR Therapeutics AG (NASDAQ:CRSP), a leader in gene-editing based therapeutics, and MaSTherCell SA, a utter service contract development and manufacturing organization (CDMO), wholly-owned subsidiary of Orgenesis Inc. (OTCQB:ORGS), today announced the signing of an agreement to develop and manufacture allogeneic CAR-T therapies.
MaSTherCell will be responsible for the development and cGMP manufacturing of CTX101 for use in clinical studies. CTX101 is an allogeneic CAR T-cell therapy presently in development by CRISPR Therapeutics for the treatment of CD19 positive malignancies. The program utilizes CRIPSR`s proprietary gene-editing technology to make targeted modifications to the T-cell, thereby enabling an allogeneic, or off-the-shelf, product that is applicable to a broader patient population and addresses the industrialization challenges of the current generation of autologous therapies.
«The signing of this agreement represents an significant milestone for CRISPR Therapeutics as it not only demonstrates our progress with CTX101, but also lays the foundation for our broader activities and emerging pipeline in the allogeneic cell therapy field.» said Jon Terrett, Head of Immuno-Oncology Research and Translation at CRISPR Therapeutics.
«We`re indeed excited to have initiated work with MaSTherCell. Their market-leading capabilities and deeply relevant practice stood out as we looked for a playmate to help accelerate our pre-clinical programs towards the clinic in both the US and Europe.» added Samarth Kulkarni, President and Chief Business Officer at CRISPR Therapeutics.
MaSTherCell provides process optimization and manufacturing services to cell therapy organizations. It has quickly built the most extensive practice in the field and is focused on developing solutions to the industrialization challenges facing the cell therapy sector.
«We are looking forward to working with CRISPR Therapeutics. They have made significant progress to date with multiplexed gene editing and this provides a solid platform upon which we can bring to bear MaSTherCell`s significant practice in the manufacturing of allogeneic cell therapies.» said Denis Bedoret, General Manager at MaSTherCell.
Movie: Affordable Breakthrough Therapies, Interview with Denis Bedoret
11.04.2017
Denis Bedoret, General Manager at MaSTherCell, shares his view on the cell therapy market and what is next for MaSTherCell. Click to witness the movie!
Servier appoints MaSTherCell for the development of its CAR-T cell therapy manufacturing platform
Legitimate.01.2017
Downloads
- Download the press release
Related Pages
Suresnes, France and Brussels, Belgium – eighteen January two thousand seventeen – Servier , the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the s igning of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies.
Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier cell therapy products. This is a critical step in development of these products for later stage clinical trials.
Cell therapies have shown promising results in treating cancers. However so far, successful development has been mainly limited to autologous therapies. This treatment, where the patient`s cells are collected then used to create a drug for that specific patient, is limited by the lack of possibility of industrialized manufacturing, thus restricting its access to few patients. Allogeneic therapies, or off-the-shelf treatments, potentially suggesting the technology to a higher number of patients, are developing very rapidly. However the challenges of their manufacturing scale-up still lie ahead.
One of the most advanced cell therapies is based on CAR-T technology, where the T-cells are armed with a Chimeric Antigen Receptor. Servier is developing UCART-19 (see below About UCART-19 for more information), with two clinical trials presently ongoing in Europe, in relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL), in pediatric and adults patients.
Servier selected MaSTherCell because of its leading global cell therapy CDMO position as well as its essential broad expertise in immunotherapy products. MaSTherCell has a track record of designing and delivering cost-effective cell therapy manufacturing platforms.
MaSTherCell anticipates that it will finish the development of the initial CAR-T platform in 2018. This will then be an efficient complement to the bioproduction facilities that Servier is developing at its site at Gidy (France), which will mainly concentrate on the production of antibodies.
«This partnership will result in developing solutions for one of the thickest challenges to the ongoing development of the cell therapy sector. MaSTherCell has quickly built the most extensive CDMO practice in manufacturing and process industrialization development in the cell therapy industry,» said Denis Bedoret, CBO at MaSTherCell. «This enables MaSTherCell to leverage that practice to produce solutions to contribute to the Servier cell therapy pipeline. We will thus be able to directly contribute to delivery of life-saving cell therapy treatment to patients».
«The scale up of manufacturing for late scale clinical trials still remains one of the largest industry-wide challenges in the cell therapy sector, and especially in a CAR-T field still in its infancy,» said Marielle Anger-Leroy, Director of Biotechnology Industrial Development at Servier. «Being pioneers with these innovative therapies means that we have to find the best playmates to maximize the chances of delivering these therapies to patients with few alternative options.»
MaSTherCell – News – Servier appoints MaSTherCell for the development of its CAR-T cell therapy manufacturing platform
MaSTherCell
01.08.2017
Related Pages
Have an insight of the industry with Denis Beboret, Managing Director at MaSTherCell.
Detect how MaSTherCell is enabling cell therapy development, Interview with Denis Bedoret
25.07.2017
Outward Links
Related Pages
In this interview, Denis Bedoret, Managing Director at MaSTherCell, shares how the cell therapy industry has evolved in latest years and explains how MaSTherCell can help cell therapy companies.
- What are the challenges encountered in the industry?
- What is the MaSTherCell’s advantage?
- How can MaSTherCell help?
- The insight of the future of the cell therapy industry
CRISPR selected MaSTherCell for the development and cGMP manufacturing of CTX101
06.06.2017
Downloads
- Download the press release
Outward Links
Related Pages
BASEL, Switzerland, CAMBRIDGE, Mass. & Gosselies, Belgium. Jun 6, 2017 – CRISPR Therapeutics AG (NASDAQ:CRSP), a leader in gene-editing based therapeutics, and MaSTherCell SA, a utter service contract development and manufacturing organization (CDMO), wholly-owned subsidiary of Orgenesis Inc. (OTCQB:ORGS), today announced the signing of an agreement to develop and manufacture allogeneic CAR-T therapies.
MaSTherCell will be responsible for the development and cGMP manufacturing of CTX101 for use in clinical studies. CTX101 is an allogeneic CAR T-cell therapy presently in development by CRISPR Therapeutics for the treatment of CD19 positive malignancies. The program utilizes CRIPSR`s proprietary gene-editing technology to make targeted modifications to the T-cell, thereby enabling an allogeneic, or off-the-shelf, product that is applicable to a broader patient population and addresses the industrialization challenges of the current generation of autologous therapies.
«The signing of this agreement represents an significant milestone for CRISPR Therapeutics as it not only demonstrates our progress with CTX101, but also lays the foundation for our broader activities and emerging pipeline in the allogeneic cell therapy field.» said Jon Terrett, Head of Immuno-Oncology Research and Translation at CRISPR Therapeutics.
«We`re indeed excited to have initiated work with MaSTherCell. Their market-leading capabilities and deeply relevant practice stood out as we looked for a playmate to help accelerate our pre-clinical programs towards the clinic in both the US and Europe.» added Samarth Kulkarni, President and Chief Business Officer at CRISPR Therapeutics.
MaSTherCell provides process optimization and manufacturing services to cell therapy organizations. It has quickly built the most extensive practice in the field and is focused on developing solutions to the industrialization challenges facing the cell therapy sector.
«We are looking forward to working with CRISPR Therapeutics. They have made significant progress to date with multiplexed gene editing and this provides a solid platform upon which we can bring to bear MaSTherCell`s significant practice in the manufacturing of allogeneic cell therapies.» said Denis Bedoret, General Manager at MaSTherCell.
Movie: Affordable Breakthrough Therapies, Interview with Denis Bedoret
11.04.2017
Denis Bedoret, General Manager at MaSTherCell, shares his view on the cell therapy market and what is next for MaSTherCell. Click to see the movie!
Servier appoints MaSTherCell for the development of its CAR-T cell therapy manufacturing platform
Legitimate.01.2017
Downloads
- Download the press release
Related Pages
Suresnes, France and Brussels, Belgium – eighteen January two thousand seventeen – Servier , the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the s igning of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies.
Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier cell therapy products. This is a critical step in development of these products for later stage clinical trials.
Cell therapies have shown promising results in treating cancers. However so far, successful development has been mainly limited to autologous therapies. This treatment, where the patient`s cells are collected then used to create a drug for that specific patient, is limited by the lack of possibility of industrialized manufacturing, thus restricting its access to few patients. Allogeneic therapies, or off-the-shelf treatments, potentially suggesting the technology to a higher number of patients, are developing very rapidly. However the challenges of their manufacturing scale-up still lie ahead.
One of the most advanced cell therapies is based on CAR-T technology, where the T-cells are armed with a Chimeric Antigen Receptor. Servier is developing UCART-19 (see below About UCART-19 for more information), with two clinical trials presently ongoing in Europe, in relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL), in pediatric and adults patients.
Servier selected MaSTherCell because of its leading global cell therapy CDMO position as well as its essential broad expertise in immunotherapy products. MaSTherCell has a track record of designing and delivering cost-effective cell therapy manufacturing platforms.
MaSTherCell anticipates that it will accomplish the development of the initial CAR-T platform in 2018. This will then be an efficient complement to the bioproduction facilities that Servier is developing at its site at Gidy (France), which will mainly concentrate on the production of antibodies.
«This partnership will result in developing solutions for one of the largest challenges to the ongoing development of the cell therapy sector. MaSTherCell has quickly built the most extensive CDMO practice in manufacturing and process industrialization development in the cell therapy industry,» said Denis Bedoret, CBO at MaSTherCell. «This enables MaSTherCell to leverage that practice to supply solutions to contribute to the Servier cell therapy pipeline. We will thus be able to directly contribute to delivery of life-saving cell therapy treatment to patients».
«The scale up of manufacturing for late scale clinical trials still remains one of the thickest industry-wide challenges in the cell therapy sector, and especially in a CAR-T field still in its infancy,» said Marielle Anger-Leroy, Director of Biotechnology Industrial Development at Servier. «Being pioneers with these innovative therapies means that we have to find the best playmates to maximize the chances of delivering these therapies to patients with few alternative options.»